Pharmacovigilance in Panama: reporting with VigiMedic and VigiVac

VigiMedic and VigiVac in Panama: what the DNFD launched

On September 15, 2026, the National Directorate of Pharmacy and Drugs (DNFD) of the Ministry of Health (Minsa) presented two reporting apps in Panama: VigiMedic Panamá, for suspected adverse drug reactions, and VigiVac Panamá, for events supposedly attributable to vaccines or immunization¹. National deputy director Alicia Castillo presented the launch details; Edgar Domínguez, head of the Pharmacovigilance Department, explained how the apps work; and Miguel Díaz of the National Pharmacovigilance Center presented their benefits¹.

Health professionals and patients can report, from cell phones, tablets, laptops or desktop computers. Access is through the DNFD website, which offers links, QR codes and instructions for submitting a report correctly¹. On the DNFD site, the reporting section says professionals and patients can notify through VigiMedic and VigiVac¹¹.

Which platform to use: VigiMedic, VigiVac or FADDI

For the physician, the practical question is where each report goes. According to the DNFD: a suspected adverse drug reaction goes to VigiMedic; an event possibly attributable to a vaccine goes to VigiVac; and suspected therapeutic failures and quality defects, for medicines and vaccines alike, are reported separately in FADDI, the DNFD's digital platform, whose information was reinforced at the launch¹. The DNFD site menu also lists FADDI under its procedures¹¹.

• Patient with an unexpected reaction to a registered drug: VigiMedic¹².
• Event after a vaccine: VigiVac. Surveillance of these events (ESAVI) was reviewed in August 2025 by a PAHO/WHO technical mission with Minsa and the Social Security Fund (CSS)¹⁹.
• The product does not perform as it should or arrived with a defect (vial, seal, appearance): FADDI¹.
• Product suspected of being falsified: Minsa's national campaign says such reports go through the DNFD's official portal and are coordinated with Customs and the Public Prosecutor's Office⁸.

Medication Safety Week 2026

From November 2 to 8, 2026, Minsa, through the DNFD, its Pharmacovigilance Department and the National Pharmacovigilance Center, launched MedSafety Week in Panama with the slogan do not ignore adverse effects and report them². The opening webinar brought together Minsa, the CSS and the pharmaceutical industry. National director of Pharmacy and Drugs Uriel Pérez spoke; Edgar Domínguez, Odalis Guanti of the CSS Institutional Pharmacovigilance Center, and Mario Torrero, representing industry, took part².

The legal framework: Law 419 and Executive Decree 27 of 2024

Law 419 of February 1, 2024, Panama's medicines law, lists among its key points the regulation of pharmacovigilance and medicine quality¹⁰. Its regulation is Executive Decree 27 of May 10, 2024. According to the DNFD's presentation on VigiFlow eReporting Industry, Article 315 obliges national and foreign manufacturing laboratories and distribution agencies to report suspected adverse drug reactions; Article 317 requires them to maintain a pharmacovigilance system; and Article 318 calls for access to the MedDRA and WHODrug coding systems for electronic reporting³.

The same presentation adds that the official implementation date for reporting with WHODrug and MedDRA standards is March 2026, based on Resolution 118 of May 9, 2025, and that industry reports go to the National Pharmacovigilance Center and can be shared with VigiBase, the WHO-UMC database³. Important: what we reviewed describes industry obligations; those slides do not set a duty or penalty for the individual physician, and this article does not claim one.

Why it matters with falsified and unregistered products

The DNFD has warned about the problem for some time. In September 2025 it reported that since 2024 it had issued 56 alerts on falsified medicines in the Americas, and that Operation Pangea XV (2022) seized 275,075 units without sanitary registration⁶⁵. On September 1, 2026, Minsa launched a national anti-falsification campaign in alliance with Customs, the Public Prosecutor's Office, the Ministry of Public Security and the University of Panama⁸. On September 7, 2026 it warned about falsified oncology monoclonal antibodies offered through social media and websites, and said the DNFD monitors those channels⁷.

On GLP-1 analogues, PAHO/WHO issued a regional epidemiological alert on their misuse on February 27, 2026. It urges states to strengthen pharmacovigilance, promote timely reporting of adverse events and ensure that every report, whatever its entry point, is formally channeled to the regulatory authority or the national pharmacovigilance center, to guarantee traceability, causality analysis and benefit-risk assessment⁴. Its risk table includes falsified or unauthorized products bought online and through informal channels, with absent active ingredient, contamination or loss of cold chain⁴. We covered the Panamanian context in falsified GLP-1 products in Panama and in registration, prices and the CSS.

The practical consequence for the physician: an adverse event with a product of doubtful origin, mentioned in a chat or on social media, does not exist for the system. Reported in VigiMedic or FADDI, it enters a national database that can detect signals. If the lot and packaging are also kept, the DNFD has something to work with. To tell a genuine certificate from a decorative one, see how to verify a COA and a lot in Panama.

Reporting is not accusing: suspicion, not causality

A report is a suspicion. The DNFD names it that way in its platforms and slogan¹², and PAHO frames it the same way when it notes that signals such as diabetic retinopathy progression with GLP-1 agonists are under evaluation and do not constitute confirmation of a causal relationship⁴. The physician does not have to prove the drug caused the event in order to report it; causality analysis belongs to the system⁴.

Under-reporting is a documented problem. A systematic review in Drug Safety (2006) analyzed it under the title «Under-reporting of adverse drug reactions»¹², and a 2023 update reviewed the factors associated with under-reporting by health care professionals¹³. Panama, with new apps and a campaign week, is betting on narrowing that gap. Without published data on how many reports have arrived since the launch, we cannot yet say whether it is succeeding.